Biotech Pharmaceutical Medical Equipment and Supplies - Analysis - May 2023.pptx

1. BIOTECH, PHARMACEUTICAL, AND HEALTHCARE SECTOR Paul Young CPA CGA May 1, 2023

2. PAUL YOUNG - BIO • CPA, CGA (1996) • Academia (PF1, FA4, FN2, MU1. and MS2) • SME – Customer Success Management • SME – Adoption of Cloud Platform • SME – Risk Management • SME – Close, Consolidate and Reporting • SME – Public Policy • SME – Emerging Technology • SME – Business Process Change • SME – Financial Solutions • SME – Macro/Micro Indicators • SME – Supply Chain Management • SME – Data, AI, Security, and Platform • SME – Internal Controls and Auditing Contact information email: Paul_Young_CGA@outlook.com LinkedIn: https://www.linkedin.com/in/paul-young-055632b/ SlideShare - https://www.slideshare.net/paulyoungcga

3. AGENDA VACCINE PRODUCTION • Drug Discovery/Pharmaceutical Market • Vaccine Production – Top 10th • Vaccination Licensing / Production Canada • DNA sequencing • Biotech and AI • Blog – Vaccination and Production • Life Sciences Strategy • Breakthroughs with storage and distribution of vaccines • Blog - AI-Based imaging analysis tools and cloud-based deployments to bolster digital pathology market • Infused AI • Chatbots

4. DRUG DISCOVERY AND PHARMACEUTICAL MARKET • Outsource drug discovery market - https://www.prnewswire.com/news-releases/global-5-4-billion-drug- discovery-outsourcing-market-to-2028--301235637.html • Drug Discovery informatics - https://www.prnewswire.com/news-releases/drug-discovery-informatics- market-size-worth-5-63-billion-by-2028-grand-view-research-inc-301232269.html • Pharmaceuticals Market - https://www.globenewswire.com/news- release/2020/04/27/2022157/0/en/Pharmaceuticals-Market-to-Reach-USD-1-310-0-Billion-in-2020- Eruption-of-the-COVID-19-Pandemic-to-Accelerate-the-Demand-for-Effective-Treatments-and-Drugs- Worldwide-Fortune-Business.html

5. EFFICACY OF DRUGS AND TREATMENT • Efficacy - https://pharmanewsintel.com/news/ai-in-the-pharma-industry-current-uses-best-cases- digital-future • Clinical trials - https://imagia.com/machine-learning-understanding-differences-between-real-world- evidence-and-clinical-trial-data-for-better-patient-outcomes-2/ • Hitting the bullseye - https://www.astrazeneca.com/what-science-can-do/topics/disease- understanding/Hitting-the-bullseye-finding-better-targets-for-drug-development.html

6. VACCINE PRODUCTION Top 10 – Vaccine Manufacturing 1. Glaxo Welcome 2. Merck and Company 3. Sanofi 4. Pfizer 5. Novavax 6. Emergent BioSolutions 7. CSL 8. Inovio Pharmaceuticals 9. Bavarian Nordic 10. Mitsubishi Tanabe Source - https://blog.technavio.com/blog/top-10- vaccine-manufacturers • Contract manufacturing - https://www.contractpharma.com/contents/view_breaking- news/2020-10-26/3p-biopharmaceuticals-and-spybiotech-enter- vaccine-contract-manufacturing-agreement/ • Contract manufacturing - https://www.contractpharma.com/content-microsite/covid- 19/2020-11-24/curevac-and-wacker-sign-contract-for- manufacturing-of-covid-19-vaccine-candidate • USA, Germany, and United Kingdom - https://gmpnews.net/2020/11/us-uk-and-germany-are-top- manufacturers-for-covid-19-vaccines/ • Mass production challenges - https://www.cnbc.com/2020/11/18/what-are-the-big-challenges- to-mass-producing-a-coronavirus-vaccine.html • Vaccines / Australia - https://www.cslbehring.com/vita/2020/csl- starts-manufacturing-a-potential-covid19-vaccine • Japan / Takeda - https://www.takeda.com/newsroom/newsreleases/2020/takeda- expands-covid-19-vaccine-supply-in-japan-through-- partnership-with-moderna-and-government-of-japan/

7. VACCINATION LICENSING • Regulations / Canada - https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/activities/fact-sheets/regulation- vaccines-human-canada.html • Biotech Canada / 2016 Paper • In Canada, annual vaccine sales are estimated at roughly $Cdn 450 million. Recent data from the Canadian Institute for Health Information (CIHI) regarding Canada’s total health care spending helps put vaccine spending into appropriate perspective; vaccine spending represents a small percentage (4.0%) of Canadian public health expenses, and an extremely small fraction (<0.3%) of national health care expenditures in 2008 • Despite the tremendous value of vaccines – and their proven impact on public health – fewer companies are currently investing in the vaccine market sector worldwide. The global vaccine industry has recently undergone significant consolidation; over the past 30 years, the number of companies engaged in the development and manufacturing of vaccines has declined from roughly 25 to five. 44 Potential factors that have contributed to the decision for several companies to abandon their vaccine production lines (including, among other challenges, complexity of development, production and quality control) are discussed in further detail in Paper 7 regarding manufacturing and supply issues. • As of early 2009, the Canadian vaccine landscape mirrors the highly concentrated structure of the global vaccine marketplace, with the “top tier” vaccine companies currently including GlaxoSmithKline (GSK) Canada, Merck Canada Ltd., Novartis, Pfizer Canada (formerly Wyeth Pharmaceuticals Canada), and Sanofi Pasteur. All these players represent Canadian divisions of the respective multinational companies headquartered in Europe (GSK, Novartis, Sanofi Aventis) or the United States (Merck, Pfizer). While Sanofi Pasteur has a large-scale vaccine manufacturing • facility based in Toronto (known as the Connaught Campus),45 GSK has vaccine production facilities in Québec City and Laval, Québec.46 These Canadian facilities supply vaccines for global clinical trials and/or commercial sales (e.g. for influenza and acellular pertussis vaccines, by GSK and Sanofi Pasteur, respectively). Merck, Novartis, and Pfizer do not presently have vaccine manufacturing facilities in Canada. Key vaccines of the five top tier companies that are currently available on the Canadian market are listed in Table 2.4. Further details are provided in Paper 5 (Tables 5.1 and 5.2) regarding these and other vaccines approved in Canada for infants, children, • Source - www.biotech.ca vaccines_2_2010.pdf

8. INNOVATION • Storage/shipments of vaccines - Researchers in Ontario have developed a new method of transporting life-saving vaccines to remote and impoverished regions of the world at only a fraction of the cost of current techniques. The research team from McMaster University in Hamilton, Ont. has found a way to eliminate current costly refrigeration methods or “cold-chain constant storage,” which stores vaccines at a temperature between 2 C and 8 C in order to keep them viable. In a study published Tuesday in the journal Scientific Reports, the academics share a new method of transportation that only requires two sugars that are already approved by the U.S. Food and Drug Administration (FDA) and Health Canada. Leung said they mix the two sugars -- trehalose and pullulan – together with existing vaccines into a sugary gel. The combination allows the active ingredients in the vaccines to remain viable for eight weeks or more in elevated temperatures up to 40 C, according to the researchers. Source - https://www.ctvnews.ca/health/new-made-in-canada-technique-could-revolutionize-vaccine- transportation-1.4430517 • Vaccine production / innovation - https://www.mckinsey.com/industries/pharmaceuticals-and-medical- products/our-insights/refueling-the-innovation-engine-in-vaccines# • USA / Warp Speed - https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

9. THE GLOBAL PHARMACEUTICAL MARKET Source - https://www.statista.com/statistics/309457/world-pharmaceutical-revenue-distribution-by- technology/

10. GDP PHARMA AND BIOTECH SECTOR Source – Stats Canada

11. BLOG – NEAR-SHORING A trade war with China and the disruptive effects of the COVID-19 pandemic have U.S. companies starting to question a decades-old strategy of shifting manufacturing operations to low-cost labor markets in China and other Asian nations. Some are starting to invest in expanding or building new factories in the U.S. and its nearby trade partners, Mexico, and Canada. Such moves are known as reshoring — for the U.S. — and nearshoring in Mexico and Canada. If the trend accelerates, it will create a domestic manufacturing boom and alter trucking routes, shifting some import-centric traffic from Southern California’s massive port complex to manufacturing hubs across the U.S., according to analysts. A June survey by Thomas, a New York-based industrial sourcing platform, found that 69% of businesses said they are “likely” to “extremely likely” to re-shore operations to bolster their supply chains — up from 54% in a previous survey in February, just before the pandemic took hold. Source - https://www.ttnews.com/articles/2020-events-force-manufacturers-rethink-reshoring-operation-plans Summary • All levels of government need to work together to develop economic policies that will support the reshoring of critical parts of the supply chain • It is very competitive when it comes to attracting foreign direct investment (FDI). Countries need to take a hard look at their policies related to regulations and taxes - https://www.slideshare.net/paulyoungcga/path-to-innovation-for-canada Here is my work on supply chain - https://www.slideshare.net/paulyoungcga/how-best-to-reshore-your-supply-chain-management-system- 241186222

12. LIFE SCIENCES STRATEGY Pandemic-preparedness plan can be start of life-sciences strategy - https://www.linkedin.com/pulse/pandemic-preparedness-plan-can-start-life-sciences-strategy- young/?published=t There are many pieces to a life-sciences strategy including the coordinating of biotech/pharmaceuticals on drug research and discovery, expanding AI into the drug discovery process, etc. Here is my work on biotech/pharmaceutical: https://www.slideshare.net/paulyoungcga/biotech-and-pharmaceutical- september-2021 There are also issues with how both the private and public sectors deal with geopolitical events including crisis management. I have called out the following issues: a) Lack of audited crisis management reports and processes for all levels of governments b) Lack of oversight including performance audits of WHO c) Lack of homegrown vaccination production d) Lack of exit strategy when it comes to transitioning off pandemic programs e) Lack of focus on protecting the environment while growing the economy in a sustainable way f) Lack of building a resilient supply chain g) Revamping EI plans as part of transitioning people to do jobs of today and tomorrow Blog – Geopolitical Risks and Events – Global Viruses (Healthcare) – October 22, 2021 - https://www.slideshare.net/paulyoungcga/geopolitical-eventscovid19canada-and-the-world-october-22-2021 or https://www.slideshare.net/paulyoungcga/geopolitics-risk-and-threats-variants-and-disease-management-august-27-2022pptx

13. DATA, AI, SECURITY AND PHARMACEUTICALS • IBM and peptides - https://www.ibm.com/blogs/research/2021/03/ai-finds-new-peptides/ • Internal Audit - https://www.slideshare.net/paulyoungcga/business-analytics-and-audit-analyticspptx • Close, consolidate and reporting – https://www.slideshare.net/paulyoungcga/close-consolidate-and-reporting-cyclepptx- 256864692 • HIPAA - https://compliancy-group.com/hipaa-compliance-and-ai-solutions/ • Rules around accessing data and how it is to be used • Disease Management • Data and AI - https://www.pwc.com/gx/en/industries/healthcare/publications/ai-robotics-new-health/transforming-healthcare.html • Online Pharmacies - Market Research Future (MRFR) evaluates that the Global ePharmacy Market is anticipated to acquire a market value of USD 164,829.5 Million while expanding at a CAGR of 12.5% by 2027. • AI can play a role in terms of data governance and oversight - https://www.slideshare.net/paulyoungcga/strengthen-internal-controls-and- compliance-through-data-and-ai-as-part-of-the-regulatory-and-corporate-reporting-cyclepptx

14. BIOTECH AND PHARMA AI On Mar. 16, Amgen announced that it had entered a multi-year partnership with Mila – Quebec Artificial Intelligence Institute. As a global biotechnology company, Amgen uses science and technology to discover and develop therapeutics, and AI is currently deployed in several of its R&D and manufacturing activities. This new partnership will permit Amgen to expand its knowledge of AI and deep learning by interacting and engaging with experts in Mila’s unique ecosystem, both virtually and (eventually) on the Mila campus in Montreal. This announcement was made during Effervescence 2021, an international virtual gathering of scientists, entrepreneurs and industry professionals from the life sciences and health technology sectors in the presence of the Quebec Minister of Economy and Innovation, Pierre Fitzgibbon. Source - https://www.canadianmanufacturing.com/manufacturing/amgen-announces-artificial-intelligence- partnership-with-mila-267908/

15. BLOG - AI-BASED IMAGING ANALYSIS TOOLS AND CLOUD-BASED DEPLOYMENTS TO BOLSTER DIGITAL PATHOLOGY MARKET • AI-Based imaging analysis tools and cloud-based deployments to bolster digital pathology market – Healthcare and Drug Discovery and Pharmacy Management - https://www.linkedin.com/pulse/blog-ai-based-imaging- analysis-tools-cloud-based-bolster-paul-young

16. MAXIMO AND PHARMA

17. CHATBOTS

18. AI AND DRUGS

19. SUMMARY • Pharma and biotech continue to look at AI as part of the drug discovery and manufacturing processes • Public sector governance model - https://ibm.box.com/s/x9s1qxfvcgwzrseh7ls5vwk42sgsapa6 • Drug costs continue to plague world governments - https://www.forbes.com/sites/eriksherman/2022/06/27/why-wont-congress-do-what- mark-cuban-is-doing-for-affordable-drug-prices/?sh=67c76142703b • Medical equipment reshoring https://www.inddist.com/supply-chain/article/22223176/print-reshoring-ppe-the-right-way-to-prepare-for- future-pandemics or https://www.mddionline.com/regulatory-quality/building-better-medical-device-supply-chain • 3D printing and medical - https://www.aha.org/aha-center-health-innovation-market-scan/2022-06-07-3-ways-3d-printing-revolutionizing- health-care • Healthcare delivery model - https://www.theglobeandmail.com/canada/article-medical-association-tells-mps-to-work-on-health-care- crisis-this/ or https://www.slideshare.net/paulyoungcga/global-healthcare-crisis-pptx Blog – Pharmaceut i cal Biotech Medical Supplies and Equipment – Analysis – May 2023 Summary: Healthcare, pharma, and biotech cont i nue to look at how best to deploy data and AI as part of their various product lifecycles. Healthcare cont i nues to look at ways to automate various operat i onal aspects. The key will be how to secure, store, and ingest the data as part of improving pat i ent outcome. EMEA count i es to move forward with key policy changes like DORA, CRA, and ESG report i ng. Addit i onal sources: CRA - https://www .jdsupra.com/legalnews/increasing-global-cybersecurity-2465749/ Data and AI - https://medcitynews.com/2023/04/smart-medicine-art i fi cial-intelligence-is-shaping-drug- discovery-and-development-in-ways-never-once-imagined/ Data and AI medical equipment and supplies - https://www .medicalplast i csnews.com/medical-plast i cs- industry-insights/medical-plast i cs-thought-leadership/ai-and-the-evolving-career-path-of-regulatory- professionals/ or https://www .aaii.com/invest i ngideas/art i cle/54661-3-undervalued-medical- equipment-supplies--distribut i on-stocks-for-friday-april-28 Medical monitoring - https://www .plugandplaytechcenter .com/resources/10-remote-pat i ent- monitoring-companies-you-should-know-about/ Healthcare technologies - https://www .selecthub.com/medical-software/top-health-it-security-trends/ ‘ Homecare - https://www .marketwatch.com/press-release/with-72-cagr-us-home-healthcare-services- market-future-est i mat i on-outlook -complete-strategic-analysis-2029-2023-04-26?mod=search_headline

Biotech Pharmaceutical Medical Equipment and Supplies - Analysis - May 2023.pptx

Biotech Pharmaceutical Medical Equipment and Supplies - Analysis - May 2023.pptx

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Biotech Pharmaceutical Medical Equipment and Supplies - Analysis - May 2023.pptx